Global Lead Clinical QA Auditor - GCP & ISA
IQVIA LLC
IQVIA is seeking a QA Auditor to independently lead the full audit lifecycle for Investigator Site Audits across a diverse portfolio of clinical research programs. The role requires coordinating with global teams, evaluating findings, and preparing CAPA plans while ensuring adherence to GCP and regulatory requirements.
The position involves travel 30–50% mainly in Europe, with a strong emphasis on quality compliance and continuous improvement within a global quality organization.
#J-18808-LjbffrOfferta di lavoro pubblicata 1 giorno fa
Offerte di lavoro simili
- ...Overview In this role you lead strategic delivery of global clinical trials, partnering with sponsors and cross-functional teams to accelerate development... ...alignment Ensure studies comply with ICH-GCP, regulatory requirements, and contractual commitments...GCP
- ...As a Quality Assurance Auditor, you will plan and conduct independent GCP audits across IQVIA contracts... ...maintain the eQMS, and lead QA initiatives, including... ...to reliable, compliant clinical research operations. You... ...education work in a leading global clinical research...GCP
47.500 € - 71.300 €
...and conduct independent clinical (GCP) audits to assess... ...opportunity to independently lead audit activities across... ...and collaborate with global teams to support quality... ...Inspections or during similar QA activities as assigned.... ...Site Audits (ISAs) across a diverse portfolio...GCPPart-timeTempo pienoDisponibilità immediata- ..., Italy, seeks a Senior Director, Biostatistics Lead to drive statistical strategy across therapeutic areas and clinical development. You will provide SME input on plans... ...deliverables. The role requires deep expertise in GCP/ICH, CDISC SDTM/ADaM, and advanced statistical...GCP
- ...Associate Medical Director to provide medical leadership and advice for clinical trials within the PPD Pharmacovigilance portfolio. You will... ..., and liaison activities with sponsor and regulatory bodies, while guaranteeing adherence to SOPs and GCP. /p #J-18808-LjbffrGCP
- ...this role you will manage day-to-day clinical trial operations and serve as the... ...while ensuring compliance with ICH/GCP and regulatory standards. You’ll lead cross-functional teams, oversee vendors... ...a strong focus on impact through global trial execution. Retribuzione /...GCPOrario flessibile
- ...guidelines. You will partner with the Clinical team, sponsors, and vendors to... ...timely status updates. You’ll lead cross-functional study... ...This role offers impact across global projects in a values-driven... ...studies to meet scope, budget, ICH GCP, FDA regulations, and...GCP
- ...Overview In this Clinical Trial Manager role, you will oversee day-to-day trial operations... ...strong path for professional growth within a globally recognized CRO. Retribuzione /... ...collaboration Problem solving ICH/GCP knowledge Study protocol review Data...GCPRemotoOrario flessibile
- pBeOne Medicine is seeking an experienced Clinical Research Associate to monitor oncology/hematology trials across sites. You will perform... ..., site selection, and monitoring visits in line with ICH-GCP and internal SOPs, ensuring data quality and safety. /ppCollaboration...GCP
- pDNV is seeking a Lead Auditor to head audits under DNV standards, ensuring independence and high quality assessments across client projects in Italy. The role requires active參Travel across the country and maintaining auditor registrations. /ppIdeal candidates are already...
- Job SummaryMedpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience... ...contract and according to ICH/GCP and all other applicable laws,... ...Our mission is to accelerate the global development of safe and...GCPRemotoLavoro da casaOrario flessibile
- ...The Trial Delivery Leader (TDL) serves as the... ...of assigned clinical trials. This role represents... ...evolution of the Global Trial Leader (GTL)... ...Leader (PDL) and co-leads the Cross-... ...program strategy. Co-lead the Cross-Functional... ...knowledge of ICH-GCP , local laws, and...GCPTempo pienoStage/TirocinioDisponibilità immediata
- ...Alira Health? Join our global team dedicated to innovation... ...Summary The Clinical Trial Liaison Manager is... ...applicable regulatory, GCP and SOP requirements and... ...defined in collaboration with Lead CSM. Conducts Sponsor... ...Inspections. May work with QA, assisting with audit...GCPRemoto
- pMedpace is seeking a Clinical Trial Manager in Milan, Italy, to lead Neuroscience and Ophthalmology studies with responsibility for day-to-day project operations... ..., protocol knowledge, and compliance with ICH/GCP across early to late-stage trials. /ppThe successful candidate...GCPStage/TirocinioRemoto
- ...Medical Director to provide medical and scientific oversight for clinical trials conducted by IQVIA Biotech Clinical on behalf of sponsor... .../ppYou will collaborate with project teams, review data, ensure GCP compliance, and contribute to protocol development, SAE reviews,...GCP
- ...with site personnel. The position requires significant travel and a strong background in clinical monitoring. The successful candidate will bring a solid understanding of ICH-GCP guidelines and capable communication skills to coordinate with sponsors, sites and...GCP
- ...Alfasigma is a privately held global healthcare company... ...company with a leading focus on Gastrointestinal... ...Director, Biostatitistics Lead. This role can be based... ...relates to all stages of clinical development for one or... ...Extensive knowledge of GCP, ICH guidelines, FDA regulations...GCPStage/Tirocinio
- ...Syneos Health Milano is seeking a Senior Clinical Research Associate II to support site monitoring in global trials. You will perform on-site and remote monitoring, ensure ICH-GCP compliance, and coordinate with sponsor teams. The role requires a Bachelor’s degree...GCPRemoto
- ...focusing on reimagining healthcare. You will empower clinicians and enhance care delivery as part of our Global Medical Operations team. Your expertise in clinical environments will be pivotal in rolling out our AI clinical operating system to significant healthcare...Tempo pieno
- ...GE HealthCare in Milano is seeking an International Clinical Education & Strategy CVUS manager to define and deploy the global clinical education strategy, ensuring clear alignment with internal stakeholders and external partners. This role drives clinical differentiation...
- ...Overview In this role you lead field audits for ICT sector schemes... ...offers continuous training, a global platform, and a strong values-... ...audit team and mentor junior auditors maintain communication with... ...fondamentali Lead Auditor experience in ICT sector schemes...Smart workingAuto aziendaleOrario flessibile
- ...and inspire and invent solutions to tackle global transformations. /p h3About The Role /h3... ...any time. /li liMaintain/acquire his/her Auditor Registration with DNV or any other... ...having been a basis for his acceptance as Lead Auditor within DNV. /li liPlan and execute...Auto aziendaleOrario flessibile
- ...You at Intertek: Unisciti al nostro team ed entra a far parte di un network globale impegnato per la qualità, la sicurezza e la sostenibilità! In qualità di Lead Auditor GMP+ entrerai nel team Business Assurance e collaborerai per attività di certificazione...Tempo pienoImpiego permanenteLibero professionista
- ...areas Purpose of the role:As the face of BSI, the role of the Lead Auditor (Client Manager) is to work closely with BSI clients to help them... ...500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups,...
40.000 € - 50.000 €
...Overview Lead the audit team to perform assessments against DNV standards and international... ...support continuous improvement within a global framework. The role blends leadership,... ...ongoing communication Maintain auditor registration and comply with qualification...Smart workingAuto aziendale- ...and inspire and invent solutions to tackle global transformations. /p h3About Business... ...any time. /li liMaintain/acquire his/her Auditor Registration with DNV or any other registration... ...been a basis for his acceptance as Lead Auditor within DNV. /li liPlan and execute...
- ...and inspire and invent solutions to tackle global transformations. About The Role... ...at any time. Maintain/acquire his/her Auditor Registration with DNV or any other registration... ...been a basis for his acceptance as Lead Auditor within DNV. Plan and execute audits...Smart workingAuto aziendaleOrario flessibile
- ...applicable regulatory requirements, SOPs and ICH GCP Assist with or oversee study start-up... ...ongoing updates of site status to Clinical Project Manager Conduct remote monitoring... .... Join an Award-Winning Team – Join a global team spanning 60 countries, recognized...GCPLavoro ibridoRemoto
- ...Overview In this role you will oversee clinical trial activities to ensure protocol alignment... ...of trial conduct. This position offers global exposure and a meaningful opportunity to... ...adherence, regulatory requirements, and GCP standards Conduct site visits to assess...GCP
- ...Overview In this role you join Medpace's Clinical Monitoring team in Italy to perform site... ...provided. This position offers growth within a global CRO focused on Phase I–IV development and... ...ensure alignment and adherence to SOPs, GCP, and regulatory requirements Verify...GCPOrario flessibile